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The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,
Prednisolone, assessed by the following measures:
Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness
Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 4 days between Visits 3 and 4.
Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo)
Duration:
Approximately 2 weeks
Controls:
Artificial Tears (Tears Naturale® II)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone | Experimental | Prednisolone Sodium Phosphate Ophthalmic Solution, 1% |
|
| Placebo | Placebo Comparator | Tears Naturale II Ophthalmic Solution, 1% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone Sodium Phosphate Ophthalmic Solution 1% | Drug | One drop in each eye, four times/day for 4 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation Change From Baseline to Day 6 | Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation). | 90 minutes post CAC |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching Change From Baseline to Day 6 | Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC | 7 minutes post-CAC |
| Ocular Redness Change From Baseline to Day 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Torkildsen, MD | Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisolone | Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days. |
| FG001 | Placebo | Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days |
| FG002 | Control | Subjects received CAC using saline instead of allergen |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prednisolone | Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inflammation Change From Baseline to Day 6 | Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation). | The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations. | Posted | Mean | Standard Deviation | score on a scale | 90 minutes post CAC |
|
AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prednisolone | Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| peri-ocular lid redness | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Lane | Ora | 9786858900 | klane@oraclinical.com |
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| Tears Naturale II Ophthalmic Solution | Drug | one drop in each eye, four times/ day (QID) for 4 days |
|
Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness). |
| 7 minutes post-CAC |
Tears Naturale II Ophthalmic Solution, 1%
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days
| BG002 | Saline | A group of three allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Tears Naturale II Ophthalmic Solution, 1%
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days
|
|
| Secondary | Ocular Itching Change From Baseline to Day 6 | Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC | The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations. | Posted | Mean | Standard Deviation | score on a scale | 7 minutes post-CAC |
|
|
|
| Secondary | Ocular Redness Change From Baseline to Day 6 | Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness). | The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations. | Posted | Mean | Standard Deviation | score on a scale | 7 minutes post-CAC |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Placebo | Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days | 0 | 5 | 0 | 5 | 1 | 5 |
| EG002 | Saline | A group of five allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization. | 0 | 3 | 0 | 3 | 0 | 3 |
| lower leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| endothelial pigment | Eye disorders | Systematic Assessment |
|
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